{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:18:32Z","timestamp":1791908312489,"version":"4.3.4"},"reference-count":49,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T00:00:00Z","timestamp":1782172800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Acute radiation-induced esophagitis (ARIE) is a common complication in non-small cell lung cancer (NSCLC) patients undergoing concurrent chemoradiotherapy (CCRT), negatively impacting their quality of life and treatment outcomes. Jishi Shuanghua Granules (JSG), a Traditional Chinese Medicine formulation, is widely used in clinical practice and has received positive feedback. However, high-quality evidence is still lacking. This study aims to evaluate the efficacy of JSG in reducing ARIE risk and severity and to explore its mechanisms through a multicenter, randomized, double-blind, placebo-controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A total of 240 stage III NSCLC patients scheduled to undergo definitive CCRT will be recruited and randomly assigned in a 1:1 ratio to either the JSG or placebo group. The primary efficacy endpoints will be the incidence rates of ARIE (\u2265Grade 1) and severe ARIE (SARIE, \u2265Grade 3) based on the Radiation Therapy Oncology Group (RTOG) criteria. Secondary efficacy endpoints will include time to first occurrence of ARIE and SARIE, ARIE-related pain and dysphagia (assessed using the Numerical Rating Scale), quality of life (measured by the Functional Assessment of Cancer Therapy-Lung questionnaire), short-term lung cancer efficacy (objective response rate and disease control rate), and long-term outcomes (progression-free survival and overall survival). Additionally, the study will explore the mechanisms of JSG through multi-omics analyses, including lymphocyte subsets, inflammatory cytokines, oxidative stress markers, gut microbiota, and metabolomics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>If the trial meets its expected outcomes, this study will provide high-quality evidence supporting the use of JSG in preventing and treating ARIE. Furthermore, integrating multi-omics analyses will help elucidate the multi-target mechanisms of JSG, contributing to a more comprehensive evidence base.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>http:\/\/itmctr.ccebtcm.org.cn\/<\/jats:ext-link>\n                      , identifier [ITMCTR2025000641].\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1814342","type":"journal-article","created":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T04:34:42Z","timestamp":1782189282000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy of Jishi Shuanghua Granules in preventing radiation-induced esophagitis in non-small cell lung cancer patients undergoing concurrent chemoradiotherapy: protocol for a 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